NCT03359187

Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial

Completed NA Last updated 4 August 2020

What this trial tests

NA trial testing Normal saline with salt/Soda in Radiation- Induced Mucositis in 120 participants. Completed in 1 March 2018.

Timeline

1 February 2016

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	Chulabhorn Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	120
Start date	1 February 2016
Primary completion	1 March 2018
Estimated completion	1 March 2018
Sites	1 location across Thailand

Drugs / interventions tested

• Normal saline with salt/Soda
• Clinacanthus nutans
• Boesenbergia rotunda

Conditions studied

• Radiation- Induced Mucositis — all drugs for Radiation- Induced Mucositis →
• Adverse Effect of Radiation Therapy — all drugs for Adverse Effect of Radiation Therapy →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Chulabhorn Hospital

Who can join

Adults 15 to 80, any sex, with Radiation- Induced Mucositis or Adverse Effect of Radiation Therapy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change of mucositis grading
  Time frame: Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy
  RTOG (Radiation Therapy Oncology Group) Grade0: none Grade 1 : oral soreness, erythema Grade 2 : oral erythema, ulcer, solid diet tolerated Grade 3 : oral ulcers, liquid diet only Grade 4 : oral alimentation impossible

Sponsor's own description

Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prophylactic management of radiation-induced mucositis using herbal mouthwash in patients with head and neck cancer: an assessor-blinded randomized controlled trial.
   Kongwattanakul S, Petchann N, Petroch P, Thanthong S, et al · · 2022 · cited 5× · PMID 35218685 · DOI 10.1515/jcim-2021-0457
2. Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
   Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4